Prevention of Delirium Among Elderly Patients With Hip Fractures

NCT03470662 | Completed

• 1 other identifier: YuFengbinDelirium
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures. Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.

Conditions

Delirium; Hip Fractures

Keywords

Hip fractures; Delirium; Aged; Care bundle

Outcome Measures

Primary Outcomes (1)

• incidence of delirium among elderly patients with hip fractures

  study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group

  3 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Care bundle

Other: Care bundle

control group

NO INTERVENTION

routine care

Interventions

Care bundle OTHER

Care bundle

experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥65 years
• with hip fractures
• treated surgically

You may not qualify if:

• \<65 years
• psychiatric history
• ICU post-operation
• refuse to join this study
• have delirium pre-operation

Sponsors & Collaborators

• Zhoupu Hospital, Pudong New Area, Shanghai, China: lead

Study Sites (1)

Zhoupu Hospital Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Delirium; Hip Fractures

Interventions

Patient Care Bundles

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedics Department

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 20, 2018
• Study Start: March 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: September 30, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

CN (1)